Devices and method for maxillary sinus lavage

ABSTRACT

A lavage catheter for the treatment of a maxillary sinus is described. The catheter comprises a proximal portion and a distal portion. The distal portion comprises an irrigation tip. The irrigation tip has a tip opening through which fluid may be delivered by one handed operation of the catheter. A method for lavaging the maxillary sinus includes inserting the lavage catheter into a patient&#39;s anatomy and advancing the irrigation tip into the maxillary sinus using one hand.

CROSS-REFERENCES TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 13/800,163 filed on Mar. 13, 2013 and published as US2013-0274600 A1 on Oct. 17, 2013, now abandoned, which claims priorityto U.S. Patent Application No. 61/675,595 filed on Jul. 25, 2012 andalso claims priority to U.S. Patent Application No. 61/623,730 filed onApr. 13, 2012, the entire disclosures of which are expresslyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates, in general, to medical devices and, inparticular, to medical devices and related methods for the treatment ofsinus conditions.

BACKGROUND OF THE INVENTION

The paranasal sinuses are hollow cavities in the skull connected bysmall openings, known as ostia, to the nasal canal. Each ostium betweena paranasal sinus and the nasal cavity is formed by a bone covered by alayer of mucosal tissue. Normally, air passes into and out of theparanasal sinuses through the ostia. Also, mucus is continually formedby the mucosal lining of the sinuses and drains through the ostia andinto the nasal canal.

Sinusitis is a general term that refers to inflammation in one or moreof the paranasal sinuses. Acute sinusitis can be associated with upperrespiratory infections or allergic conditions, which may cause tissueswelling and temporarily impede normal trans-ostial drainage andventilation of the sinuses, thereby resulting in some collection ofmucus and possibly infection within the sinus cavities. Chronicsinusitis is a long term condition characterized by persistent narrowingor blockage of one or more sinus ostia, resulting in chronic infectionand inflammation of the sinuses. Chronic sinusitis is often associatedwith longstanding respiratory allergies, nasal polyps, hypertrophicnasal turbinates and/or deviated internasal septum. While acutesinusitis is typically caused by infection with a single pathogen (e.g.,one type of bacteria, one type of virus, one type of fungus, etc.),chronic sinusitis is often associated with multiple pathogen infections(e.g., more than one type of bacteria or more than one genus ofmicro-organism).

Chronic sinusitis, if left untreated, can result in irreparable damageto the tissues and/or bony structures of the paranasal anatomy. Theinitial treatment of chronic sinusitis usually involves the use of drugssuch as decongestants, steroid nasal sprays and antibiotics (if theinfection is bacterial). In cases where drug treatment alone fails toprovide permanent relief, surgical intervention may be indicated.

The most common surgical procedure for treating chronic sinusitis isfunctional endoscopic sinus surgery (FESS). FESS is commonly performedusing an endoscope and various rigid instruments inserted through thepatient's nostril. The endoscope is used to visualize the positioningand use of various rigid instruments used for removing tissue from thenasal cavity and sinus ostia in an attempt to improve sinus drainage.

A technique known as the Balloon Sinuplasty™ procedure and a system forperforming the procedure has been developed by Acclarent Inc, of MenloPark, Calif. for treatment of sinusitis. A number of US patents andpatent applications including U.S. Pat. Nos. 7,645,272, 7,654,997, and7,803,150 describe various embodiments of the Balloon Sinuplasty™procedure as well as various devices useable in the performance of suchprocedure. In the Balloon Sinuplasty™ procedure, a guide catheter isinserted into the nose and positioned within or adjacent to the ostiumof the affected paranasal sinus. A guidewire is then advanced throughthe guide catheter and into the affected paranasal sinus. Thereafter, adilation catheter having an expandable dilator (e.g. an inflatableballoon) is advanced over the guidewire to a position where the dilatoris positioned within the ostium of the affected paranasal sinus. Thedilator is then expanded, causing dilation of the ostium and remodellingof bone adjacent to the ostium, without required incision of the mucosaor removal of any bone. The catheters and guidewire are then removed andthe dilated ostium allows for improved drainage from and ventilation ofthe affected paranasal sinus.

Before or after performing a FESS or Balloon Sinuplasty™ procedure, itmay be useful or necessary to irrigate the paranasal sinus. A devicedescribed in US 2008/0183128 , now abandoned, may be used for irrigatinga paranasal sinus. The irrigation catheter may be advanced through aguide catheter and into an ostium or the sinus for purposes of, forexample irrigation, suctioning, substance delivery and cultureretrieval.

There is a continuing need for improved methods and devices for treatingthe paranasal sinus. Although the irrigation catheter described above iseasy to use, it would be useful to provide an improved catheter forirrigating the maxillary sinuses.

SUMMARY OF THE INVENTION

In a first aspect, the invention is a catheter for the lavage of amaxillary sinus comprising a distal portion having an elongate shaftwith a bend angle of between about 90 degrees and 140 degrees. Thelavage catheter distal portion further has a distal irrigation tube thatis in coaxial arrangement with the elongate shaft. An actuator that islocated between a distal hub and a proximal hub is used for advancingthe distal irrigation tube into the maxillary sinus. The lavage catheterfurther includes a proximal portion with an irrigation luer andirrigation tubing.

In one embodiment of the lavage catheter, the irrigation tip has adistal tip opening.

In another embodiment, the irrigation tip has and one or more radiallyfacing openings.

In another embodiment the distal irrigation tube is a flexible materialselected from the group consisting of nylon, polyethylene, polyetherether ketone or polyether block amides.

In a further embodiment, the distal irrigation tube is a polyether blockamide.

In still another embodiment, the lavage catheter includes one or moredirect visualization markers.

In another embodiment, the lavage catheter includes one or moreradiographic markers.

In a further embodiment, the distal irrigation tube surrounds theelongate shaft.

In yet a further embodiment, the distal irrigation tube is surrounded bythe elongate shaft.

In still another embodiment, the lavage catheter comprises anilluminating fiber.

In another embodiment, the distal irrigation tip has a taperedconfiguration. In another aspect, the invention is a catheter for thelavage of a maxillary sinus. The catheter includes a distal portion anda proximal portion. The distal portion in includes an elongate shaftwith a bend angle of between about 90 degrees and 140 degrees, a distalirrigation tube in coaxial arrangement with the elongate shaft, and ahandle with an actuator. The proximal portion of the catheter has anirrigation luer and irrigation tubing. The actuator is useful foradvancing the distal irrigation tube into the maxillary sinus.

In one embodiment, the actuator has a light access port and the distalportion of the catheter includes an illuminating fiber.

In another aspect, the invention is a kit for the lavage of a maxillarysinus. The kit includes a catheter and an endoscope. The catheterincludes a distal portion and a proximal portion. The distal portion hasan elongate shaft with a bend angle of between about 90 degrees and 140degrees, a distal irrigation tube coaxially arranged with the elongateshaft, an illuminating fiber, and a handle with an actuator. Theactuator has a light access port for insertion of the endoscope. Theactuator is useful for advancing the distal irrigation tube into themaxillary sinus. The proximal portion of the catheter has an irrigationluer and irrigation tubing,

In another aspect, the invention includes a method for lavaging amaxillary sinus. The method includes positioning a lavage cathetercomprising a proximal portion, and a distal portion in the nasalanatomy. The distal portion comprises an irrigation tip. The methodfurther includes connecting a fluid source to the irrigation catheter;with one hand, advancing the irrigation tip into the maxillary sinus;and delivering fluid to the maxillary sinus from the fluid source thoughthe lavage catheter.

In a further embodiment, the method includes delivering the fluid at aflow rate of between 50 ml/min and 250 ml/min.

In yet another embodiment, the delivered fluid is selected from thegroup consisting of water, saline, contrast agents, antimicrobial agentsanti-inflammatory agents, decongestants, mucous thinning agents,anesthetic agents, analgesic agents, anti-allergenic agents, allergens,anti-proliferative agents, hemostatic agents, cytotoxic agents, andbiological agents or combinations of any of the above.

In another aspect, the invention is directed to a kit for the lavage ofa maxillary sinus. The kit comprises a maxillary lavage catheter and ailluminating fiber connector. The catheter comprises a distal portionand a proximal portion. The catheter distal portion comprises anelongate shaft with a bend angle of between about 90 degrees and 140degrees, a distal irrigation tube in coaxial arrangement with saidelongate shaft, an illuminating fiber, and a handle. The handlecomprises an actuator. The catheter proximal portion comprises anirrigation luer and irrigation tubing. The actuator is useful foradvancing the distal irrigation tube into the maxillary sinus. Theilluminating fiber connector connects the illuminating fiber to a lightsource, wherein the illuminating fiber connector allows for rotation ofthe catheter while the catheter is connected to the light source.

In another aspect, the invention is directed to a kit for the lavage ofa maxillary sinus. The kit comprises a catheter and fluid deliverysystem. The catheter comprises a distal portion and a proximal portion.The distal portion comprises an elongate shaft with a bend angle ofbetween about 90 degrees and 140 degrees, a distal irrigation tube incoaxial arrangement with the elongate shaft, an illuminating fiber, anda handle comprising an actuator. The proximal portion comprises anirrigation luer and irrigation tubing. The actuator is useful foradvancing the distal irrigation tube into the maxillary sinus. The fluiddelivery system provides for continuous fluid delivery to the catheter.

In a further embodiment, the fluid delivery system comprises a syringe,a fluid reservoir, a first one-way valve for directing fluid from thesyringe into the catheter when pressure is applied to the syringe and asecond one-way valve for directing fluid from the fluid reservoir intothe catheter when pressure is released from the syringe.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a medical device according to an embodiment ofthe present invention in a retracted configuration.

FIG. 2 is a side view of the medical device of FIG. 1 in an extendedconfiguration.

FIG. 3 is a side view of a further embodiment of the medical deviceaccording to the invention.

FIG. 4 is an enlarged view of the distal portion of the medical deviceof FIG. 3 in an extended configuration.

FIG. 5 is a side view of yet another embodiment of the medical deviceaccording to the invention.

FIG. 6 is an enlarged view of the distal end of the medical device ofFIG. 5 according to the invention.

FIG. 7 is a top view of still another embodiment of the medical deviceaccording to the invention.

FIG. 8 is a top view of yet another embodiment of the medical deviceaccording to the invention.

FIG. 9 is a schematic diagram of a continuous fluid injection system foruse with the medical device according to the invention.

FIG. 10A is a light cable connector for use in connecting a light cableto the medical device according to the invention.

FIG. 10B is a side cut-away view of the light cable connector of FIG.10A.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictexemplary embodiments for the purpose of explanation only and are notintended to limit the scope of the invention. The detailed descriptionillustrates by way of example, not by way of limitation, the principlesof the invention. This description will clearly enable one skilled inthe art to make and use the invention, and describes severalembodiments, adaptations, variations, alternatives and uses of theinvention, including what is presently believed to be the best mode ofcarrying out the invention.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein.

Medical devices according to embodiments of the present invention arebeneficial in that, for example, their configuration provides for aparticularly efficient preparation and treatment of a patient's sinusand is mechanically simple. Moreover, the simplicity of the medicaldevices provides for them to be manufactured in a cost effective manner.In addition, the medical device according to embodiments of the presentinvention is sufficiently stiff that it can be beneficially employed toaccess sinus anatomy followed by a convenient suction and/or irrigationof the sinus.

FIG. 1 is a side view of a maxillary lavage catheter 100 according to anembodiment of the present invention. The maxillary lavage catheter 100has a distal portion 102 and a proximal portion 106.

The distal portion 102 in the embodiment shown in FIG. 1 includes anelongate shaft 108 with sufficient stiffness to access the maxillarysinus that further includes a distal end 110 and a proximal end 112. Thedistal end 110 of the elongate shaft 108 has a bend angle that isoptimal for access to the maxillary sinus such that it can be maneuveredto access behind the uncinate process. Accordingly, the bend angle isbetween about 90° and 140°, often between about 100° and 130° and oftenabout 110° or about 120°. The elongate shaft may be of any material thatwill maintain its shape when inserted into the patient's anatomyincluding but not limited to a polymeric material selected from thegroup including but not limited to nylon, polycarbonate, and styrene, ora biocompatible metal including but not limited to stainless steel, butwill often be a stainless steel hypotube that may or may not be coatedor colored, often in black, white or blue. Alternatively, the elongateshaft 108 may be made of a malleable material including but not limitedto annealed stainless steel that can be shaped appropriately foraccessing the maxillary sinus.

The distal portion 102 of the maxillary lavage catheter 100 additionallyincludes a distal irrigation tube 114 that is in coaxial arrangementelongate shaft 108. In the embodiment shown in FIG. 1, the distalirrigation tube 114 surrounds the elongate shaft 108, but in analternative embodiment, the distal irrigation tube 114 may be surroundedby the elongate shaft 108. The distal irrigation tube 114 may be of anyflexible material that can be used to extend into the maxillary sinus aswill be described further below, including but not limited to aflexible, biocompatible polymer material, such as nylon, polyethylene,polyether ether ketone (PEEK), or polyether block amides (e.g. Pebax forexample) and that may be braided or not braided. In the embodiment shownin FIG. 1, the material is Pebax.

The distal end 110 of the distal irrigation tube 114 includes a soft,atraumatic tip 118. The soft atraumatic tip 118 may be of a lowdurometer pebax material and it may be of tapered construction for easyaccess into the maxillary sinus. The atraumatic tip 118 may further haveone or more radially facing openings to facilitate irrigation, oftenone, two or three openings of between about 0.5 to about 1.5 mm, oftenbetween about 0.8 and 1.0 mm. The lavage catheter 100 is designed toirrigate the sinus through the atraumatic tip 118 at a flow rate ofbetween about 50 ml/min and 250 ml/min and often between about 75 ml/minand 125 ml/min. The diameter of the opening 212 of the atraumatic tip isbetween about 0.5 mm and 1.5 mm, and is often between about 0.9 mm and1.0 mm. Further, instead of delivering fluid, a vacuum may be appliedand a culture may be obtained by suctioning through the atraumatic tip118.

The distal portion 102 of the maxillary lavage catheter 100 additionallyincludes a proximal hub 132 and a distal hub 136. Between the proximalhub 132 and the distal hub 136 are stiffening elements 138 and 140, andan actuator 142. The actuator 142 has a proximal end 150 and a distalend 152. The proximal end 112 of the elongate shaft 108 extends throughthe proximal hub 132 and connects to the distal end 122 of the proximalirrigation tube 120. The proximal end 115 of the distal irrigation tube114 is connected to the distal end 152 of the actuator 142. Thestiffening elements 138 and 140 extend from the proximal end of thedistal hub 136 through the actuator 142 to the distal end 160 orproximal hub 132. As shown in FIG. 1, when the proximal irrigation tube120 is fully retracted, the proximal end 150 of actuator 142 is adjacentto the distal end 160 of the proximal hub 132.

The distal hub 136 and proximal hub 132 are configured for one-handedoperation of the maxillary lavage catheter 100. The narrow portion 170of the distal hub 136 may be for grasped while the ridge 172 on theactuator 142 is pushed toward the distal hub 136 with the thumb.Alternatively, the narrow portion 170 of the distal hub 136 is may begrasped by the thumb and one or more fingers while the ridge 172 on theactuator 142 can be drawn toward the distal hub 136 with one finger. Inthis way, as is shown in FIG. 2, the distal irrigation tube 114 isextended beyond the distal end 110 of the elongate shaft 108 and intothe maxillary sinus. Similarly, removal from the nasal anatomy can beeffected by the thumb or single finger of the physician user as pressureis applied on the ridge 172, pushing it away from the nasal anatomy,retracting the distal irrigation tube 114 and the removing the maxillarylavage catheter from the nasal anatomy. In an alternative embodiment, aspring may be included to automatically retract the distal irrigationtube 114 following irrigation of the maxillary sinus. Although theembodiments shown in FIGS. 1 and 2 shown the distal irrigation tube 114coaxially surrounding the elongate shaft 108, contemplated herein isalso a configuration where in the irrigation tube elongate shaft 108coaxially surrounds the distal irrigation tube 114.

Another embodiment of the maxillary lavage catheter 800 according to theinvention is shown in FIG. 8 having a distal portion 802 and a proximalportion 804 and a light cable connector 806. In this embodiment, ahandle 808 and an actuator 810 are included on the distal portion 802 ofthe catheter 800. The handle has an opening 812 with a distal end 814and a proximal end 816. When the actuator 810 is seated against theproximal end 816 of the opening 812, the irrigation tubing (not shown,see FIG. 3) of the maxillary lavage catheter 800 is contained within themaxillary lavage catheter. When the actuator 810 is advanced in aone-handed fashion, with a single finger or thumb, and seated againstthe distal end 814 of the opening 800, the irrigation tubing (not shown,see FIG. 4) is extended out of the distal end 818 of the maxillarylavage catheter 800.

As shown in FIG. 1, the proximal portion 106 of the maxillary lavagecatheter 100 includes a proximal irrigation tube 120 with a proximal end124 and a distal end 122. The proximal end 124 of the proximalirrigation tube 120 contains a luer connector 126 and the distal endconnects to the proximal end 112 of the elongate shaft 108. The luerconnector 126 connects the proximal end 124 of the proximal irrigationtube 120 with a source of irrigation for lavage of the maxillary sinus.A syringe (e.g., having a volume of about 10 cc to about 60 cc, forexample) may be connected to luer connector 126. The syringe may be usedto drive the irrigation fluid out of the atraumatic tip 118 by handpressure by the operator on a hand pushable plunger of the syringe.Fluid pressures of about 4 to about 6 pounds per square inch (psi) aretypically generated when using a 60 cc syringe, and pressures of about15 to about 25 psi can be generated using a 10 cc syringe with flowrates of between about 50 ml/min and 250 ml/min, and often between about75 ml/min and 125 ml/min. Alternatively, the luer connector 126 may beconnected to a vacuum source to apply suction to the maxillary sinus.Further, a pulsation device may be included to achieve pulsatiledelivery of the irrigation fluid. An in-line valve assembly may beincluded between the fluid source, in this case a syringe, and thecatheter, in this case the luer connector 126. In a particularembodiment, to maximize irrigation efficiency, the valve assemblyprevents flow when the applied force is low and allows fluid to pass onethe pressure reaches a desired threshold.

Further, a pump device 900 as shown in FIG. 9 may be included to allowthe user to continuously inject irrigation fluid without having todisconnect and refill the syringe. The device 900 may be constructed ofa syringe 902 with an integrated spring 904 that serves to force theplunger 906 back in the direction of arrow 908 after the user hassqueezed the plunger 906 in the direction of arrow 910, toward thesyringe body 912 and then released the pressure. The distal end 914 ofthe syringe 902 is attached to a connector 916. The connector 916 isalso connected to a one-way exiting valve 918 and a one-way enteringvalve 920. Attached at the other side of the one-way exiting valve 918is tubing leading to the maxillary lavage catheter 100 (shown in FIG.1). Attached to the other side of the one-way entering valve 920 is afluid reservoir 922, where the reservoir may be any type of fluidreservoir such as a fluid bath or a fluid bag. In this way, when theuser pushers the plunger 906 in the direction of arrow 910, the fluid isforce through the exiting one-way valve 918 to the maxillary lavagecatheter 100. When the force on the plunger 906 is removed, the spring904 forces the plunger back, drawing irrigation fluid from the fluidreservoir 922 through the entering one-way valve 920 and into thesyringe body 912. Filling of the syringe may also be accomplished by theuser pulling back on the plunger 906.

Direct visualization markers and/or radiographic markers may be disposedalong the lavage catheter 100 distal portion 102. Generally, “directvisualization markers” refers to markers that may be viewed during usewith the naked eye or by an endoscope. In one embodiment, flexibledistal portion 102 may have a dark color, such as black, dark blue, darkgrey or the like or may be transparent, and markers may have a lightcolor, such as white, green, red or the like. In some embodiments,markers may have different colors and/or different widths to facilitatedistinguishing the markers from one another during use. This contrast incolors may facilitate viewing the markers in a darkened operation roomand/or when using an endoscope inside a patient in the presence ofblood. Additionally one or more illumination fibers may be included inthe lavage catheter 100 to confirm access of the maxillary sinus.

Lavage catheter 100 is configured to irrigate into and suction fluidsout of the maxillary sinus. Lavage catheter 100 is sized appropriatelyto be delivered into adult as well as pediatric maxillary sinuses.Lavage catheter 100 can also be used to deliver diagnostic ortherapeutic substances into the sinuses or other areas in the paranasalspace. Examples of such diagnostic or therapeutic substances include,but are not limited to: contrast agents, pharmaceutically acceptablesalt or dosage form of an antimicrobial agent (e.g., antibiotic,antiviral, anti-parasitic, antifungal, etc.), a corticosteroid or otheranti-inflammatory (e.g., an NSAID), a decongestant (e.g.,vasoconstrictor), a mucous thinning agent (e.g., an expectorant ormucolytic), an anesthetic agent with or without vasoconstrictor (e.g.,Xylocaine with or without epinephrine, Tetracaine with or withoutepinephrine), an analgesic agent, an agent (anti-allergenic agent) thatprevents of modifies an allergic response (e.g., an antihistamine,cytokine inhibitor, leucotriene inhibitor, IgE inhibitor,immunomodulator), an allergen or another substance that causes secretionof mucous by tissues, anti-proliferative agents, hemostatic agents tostop bleeding, cytotoxic agents e.g. alcohol, and biological agents suchas protein molecules, stem cells, genes or gene therapy preparations.

In the method of the invention, the distal end of the lavage catheter100 is inserted deep into the maxillary sinus. The actuator 142 is slidfrom a first position adjacent the proximal hub 132 to a second positionadjacent the distal hub 136, there by advancing the atraumatic tip 118of the distal irrigation tube 114 well into the maxillary sinus.Irrigation is performed as irrigation fluid is pushed through theopening 212 in the atraumatic tip 118 using a syringe or other fluidintroduction device attached to the luer connector 126. Once lavage iscomplete, the actuator 142 is retracted back to its first positionadjacent the proximal hub 132 and the lavage catheter 100 is removedfrom the patient's anatomy.

FIG. 3 is a side view of a maxillary lavage catheter 300 according to afurther embodiment of the present invention. Similar to the lavagecatheter 100 shown in FIGS. 1 and 2, the irrigation tube 314 coaxiallysurrounds the elongate shaft 308 (see FIG. 4). Once the distal end 310of the catheter 300 is positioned behind the uncinate near the maxillarysinus, the distal end 316 of the irrigation tube 314 is advanced bysliding actuator 342 on handle 344 in the distal direction, therebyadvancing irrigation tube 314 into the sinus where irrigation occurs.FIG. 3 shows the irrigation tube 314 prior to advancement, and FIG. 4shows the irrigation tube 314 following advancement into the sinus. Theirrigation tube 314 is sufficiently flexible to navigate through theinfundibular space, enter the sinus atraumatically, and provide adequateirrigation when flushed with sterile water, saline, or other liquid froma standard syringe or fluid injection device. Irrigation takes placethrough the elongate shaft 308 and through irrigation holes at thedistal end 316 of the irrigation tube 314. The narrow tip envelope andcurve allow for easy access and positioning behind the uncinate. Anatraumatic tip 318 prevents damage to surrounding tissue while locatingthe ostium. The small distal end 316 (approximately 1.5 mm to 2.5 mm indiameter) makes it easier to position the distal end 316 of theirrigation tube 314 behind the uncinate. This provides the irrigationtube 314 direction once it is actuated. The side irrigation holes of thedistal end 316 and front blockage at the atraumatic tip 318 allow forspray in all directions to effectively clean the sinus. The atraumaticball tip 318 minimizes the risk of tissue damage while accessing thesinus.

FIG. 5 is a side view of a maxillary lavage catheter 500 according to afurther embodiment of the present invention. In this embodiment, theirrigation tube 514 is coaxially surrounded by the elongate shaft 508(see FIG. 6). Once the distal end 510 of the catheter 500 is positionedbehind the uncinate near the maxillary sinus, the distal end 516 of theirrigation tube 514 is advanced by sliding actuator 542 in the distaldirection, thereby advancing irrigation tube 514 into the sinus whereirrigation occurs. FIG. 5 shows the irrigation tube 514 prior toadvancement, and FIG. 6 shows the irrigation tube 514 followingadvancement into the sinus. The irrigation tube 514 is sufficientlyflexible to navigate through the infundibular space, enter the sinusatraumatically, and provide adequate irrigation. Irrigation takes placethrough the elongate shaft 508 and through irrigation holes at thedistal end 516 of the irrigation tube 514. The narrow tip envelope andcurve allow for easy access and positioning behind the uncinate. Anatraumatic tip 518 prevents damage to surrounding tissue while locatingthe ostium. The small distal end 516 (approximately 1.3 mm to 2.3 mm indiameter) makes it easier to position the distal end 516 of irrigationtube 514 behind the uncinate. This provides the irrigation tube 514direction once it is actuated. The side irrigation holes and frontblockage on the atraumatic tip 518 allow for spray in all directions toeffectively clean the sinus. The atraumatic ball tip 518 minimizes therisk of tissue damage while accessing the sinus.

Delivery of the lavage catheter 100 of the current invention may beadditionally or alternatively visualized by using an endoscope or byusing fluoroscopy, electromagnetic or optical guidance, including3-dimensional visualization such as CT or MRI visualization or otherknown visualization techniques. In one embodiment of the invention, oneor more light fibers may be included in the lumen of the distalirrigation tube 114 such that advancement of the atraumatic tip 118 intothe maxillary sinus can be observed as a result of the transilluminationof the maxillary sinus. Alternatively, the distal irrigation tube 114may comprise a dual lumen tube, one lumen for irrigation and one forcontaining the light fibers for transillumination of the maxillarysinus. In the embodiment of the invention shown in FIG. 7 a light fiber(or light fibers) can be integrated into the catheter 700 at the distaltip end 702 and the actuator 704 of the handle 706. The catheter 700 maybe advanced into the sinus and positioned therein under endoscopicvisualization. Once the catheter 700 is advanced into the sinus, theendoscope may be removed so that it can be used as a light source. Thelight end of the endoscope is placed at light access point 708 byplacing it directly onto the actuator 704 as shown in FIG. 7. Thisconfiguration eliminates the need for an extra light source and requiresno additional steps by the user. After confirmation, the endoscope canbe placed back into the nasal cavity for further endoscopicvisualization.

In an alternative embodiment, an extra light source could be provided toconnect to the one or more light fibers. Connection of the one or morelight fibers to the light source can be accomplished with a rotatinglight cable connector 1000 as shown in FIGS. 10A and 10B. Using thislight cable connector 1000, the user can rotate the maxillary lavagecatheter 100 while it is attached to a light source without the weightof the light cable (not shown) inhibiting rotation.

As shown in FIG. 10B, the connector 1000 contains a grommet 1002 that isattached to the proximal end 1112 of the tubing 1004. The light fiber1006 (which may actually be one or more light fibers) is containedwithin the lumen 1008 of the tubing 1004. The grommet 1002 is designedto float freely inside the connector 1002, thereby allowing the tubing1004 to spin freely when it is rotated. The grommet 1002 is larger thanthe distal hole 1010 of the connector 1000, such that the grommet 1002,and therefore the tubing 1004 is prevented from being pulled from theconnector 1000 longitudinally.

The invention has been described with reference to certain examples orembodiments of the invention, but various additions, deletions,alterations and modifications may be made to those examples andembodiments without departing from the intended spirit and scope of theinvention. For example, any element or attribute of one embodiment orexample may be incorporated into or used with another embodiment orexample, unless otherwise specified or if to do so would render theembodiment or example unsuitable for its intended use. Also, where thesteps of a method or process have been described or listed in aparticular order, the order of such steps may be changed unlessotherwise specified or unless doing so would render the method orprocess unworkable for its intended purpose. All reasonable additions,deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

What is claimed is:
 1. A method for lavaging a maxillary sinus, saidmethod comprising: (a) positioning a distal portion of a lavage catheterinstrument in nasal anatomy of a patient, wherein the lavage catheterinstrument comprises: (i) an elongate shaft with a bend angle of betweenabout 90 degrees and 140 degrees, (ii) a distal irrigation tube incoaxial arrangement with said elongate shaft, the distal irrigation tubebeing coaxially surrounded by the elongate shaft, the distal irrigationtube having side irrigation holes and an atraumatic ball tip that blocksa distal end of the distal irrigation tube, (ii) a handle comprising:(A) a proximal end, (B) a distal end, wherein the elongate shaft extendsdistally from the distal end, and (C) an actuator, wherein the actuatoris positioned between the proximal end of the handle and the distal endof the handle, and (iv) a proximal portion comprising an irrigation luerand irrigation tubing, wherein the proximal portion extends proximallyfrom the proximal end of the handle; (b) connecting a fluid source tothe irrigation catheter; (c) with one hand, advancing the distal end ofthe irrigation tube into the maxillary sinus by sliding the actuatoralong the handle, wherein sliding the actuator along the handlecomprises sliding the actuator from a proximal position to a distalposition, wherein the proximal position is distal to the proximal end ofthe handle, wherein the distal position is proximal to the distal end ofthe handle; and (d) delivering fluid to the maxillary sinus from thefluid source though the lavage catheter.
 2. The method of claim 1wherein the delivering of the fluid occurs at a flow rate of between 50ml/min and 250 ml/min.
 3. The method of claim 1 wherein the fluid isselected from the group consisting of water, saline, contrast agents,antimicrobial agents anti-inflammatory agents, decongestants, mucousthinning agents, anesthetic agents, analgesic agents, antiallergenicagents, allergens, anti-proliferative agents, hemostatic agents,cytotoxic agents, and biological agents or combinations of any of theabove.
 4. The method of claim 1, wherein the distal irrigation tubecomprises a flexible material selected from the group consisting ofnylon, polyethylene, polyether ether ketone or polyether block amides.5. The method of claim 1, further comprising one or more directvisualization markers.
 6. The method of claim 1, further comprising oneor more radiographic markers.
 7. The method of claim 1, furthercomprising an illuminating fiber.
 8. The method of claim 1, wherein thedistal irrigation tip has a tapered configuration.
 9. The method ofclaim 1, wherein the handle further comprises one or more stiffeningelements extending longitudinally between the proximal end of the handleand the distal end of the handle, wherein sliding the actuator along thehandle comprises sliding the actuator longitudinally along the one ormore stiffening elements.
 10. The method of claim 1, wherein sliding theactuator along the handle comprises grasping one or both of the proximalend of the handle or the distal end of the handle with one or morefingers of the one hand while pushing the actuator with a thumb of theone hand.
 11. The method of claim 1, wherein sliding the actuator alongthe handle comprises grasping one or both of the proximal end of thehandle or the distal end of the handle with a thumb of the one hand andone or more fingers of the one hand while pushing the actuator withanother finger of the one hand.
 12. The method of claim 1, furthercomprising retracting the irrigation tube relative to the elongate shaftafter delivering fluid to the maxillary sinus, wherein the lavagecatheter instrument further comprises a resilient member providing aproximal bias to the actuator, wherein retracting the irrigation tubecomprises releasing relieving a distal force on the actuator, therebyallowing the resilient member to drive the actuator proximally.
 13. Themethod of claim 1, wherein the fluid source comprises a syringe, whereindelivering fluid to the maxillary sinus comprises actuating the syringe.14. The method of claim 13, wherein the fluid source further comprises areservoir coupled with the syringe, wherein delivering fluid to themaxillary sinus comprises repeatedly actuating the syringe through aplurality of actuation cycles, wherein each actuation cycle of thesyringe draws a respective volume of fluid from the reservoir.
 15. Themethod of claim 14, wherein the syringe comprises: (i) a plunger, (ii) abody, and (ii) a resilient member urging the plunger proximally relativeto the body, wherein each actuation cycle comprises advancing theplunger distally relative to the body and releasing the plunger, whereinthe resilient member moves the plunger proximally relative to the bodywhen the plunger is released.
 16. The method of claim 14, wherein thefluid source further comprises a first one-way valve, wherein the firstone-way valve is configured to permit fluid to travel from the reservoirwhile preventing fluid from traveling toward the reservoir.
 17. Themethod of claim 16, wherein the fluid source further comprises a secondone-way valve, wherein the second one-way valve is configured to permitfluid to travel to the lavage catheter instrument while preventing fluidfrom traveling from the lavage catheter instrument.
 18. A method forlavaging a maxillary sinus, said method comprising: (a) positioning adistal portion of a lavage catheter instrument in nasal anatomy of apatient, wherein the lavage catheter instrument comprises: (i) anelongate shaft with a bend angle of between about 90 degrees and 140degrees, wherein the elongate shaft has a closed distal end, (ii) adistal irrigation tube in coaxial arrangement with said elongate shaft,the distal irrigation tube being coaxially disposed about an exterior ofthe elongate shaft, the distal irrigation tube having side irrigationholes and a closed distal end, wherein the closed distal end of thedistal irrigation tube is distal to the closed distal end of theelongate shaft, (iii) a handle comprising an actuator, and (iv) aproximal portion comprising an irrigation luer and irrigation tubing,wherein the proximal portion extends proximally from the proximal end ofthe handle; (b) connecting a fluid source to the irrigation catheter;(c) with one hand, advancing the distal end of the irrigation tube intothe maxillary sinus by sliding the actuator along the handle; and (d)delivering fluid to the maxillary sinus from the fluid source though thelavage catheter.
 19. The method of claim 18, wherein the handle furthercomprises: (A) a proximal end, wherein the proximal portion extendsproximally from the proximal end of the handle, and (B) a distal end,wherein the elongate shaft extends distally from the distal end of thehandle, wherein sliding the actuator along the handle comprises slidingthe actuator from a proximal position to a distal position, wherein theproximal position is distal to the proximal end of the handle, whereinthe distal position is proximal to the distal end of the handle.
 20. Amethod for lavaging a maxillary sinus, said method comprising: (a)positioning a distal portion of a lavage catheter instrument in nasalanatomy of a patient, wherein the lavage catheter instrument comprises:(i) an elongate shaft with a bend angle of between about 90 degrees and140 degrees, (ii) a distal irrigation tube in coaxial arrangement withsaid elongate shaft, the distal irrigation tube being coaxially disposedrelative to the elongate shaft, the distal irrigation tube having sideirrigation holes, (iii) a handle comprising an actuator, and (iv) aproximal portion comprising an irrigation luer and irrigation tubing,wherein the proximal portion extends proximally from the proximal end ofthe handle; (b) connecting a fluid source to the irrigation catheter,wherein the fluid source comprises: (i) a syringe comprising a plungerand a body, and (ii) a reservoir coupled with the syringe; (c) with onehand, advancing the distal end of the irrigation tube into the maxillarysinus by sliding the actuator along the handle, and (d) delivering fluidto the maxillary sinus from the fluid source though the lavage catheter,wherein delivering fluid to the maxillary sinus comprises repeatedlyactuating the syringe through a plurality of actuation cycles, whereineach actuation cycle comprises: (i) advancing the plunger distallyrelative to the body, and (ii) retracting the plunger proximallyrelative to the body, wherein each actuation cycle of the syringe drawsa respective volume of fluid from the reservoir when the plunger isretracted proximally relative to the body.